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Re-audit of gastrointestinal tract specimens with respect to compliance with RCPath guidelines Dr Manisha Ram Dr Moina Kadri Background epidemiology and aetiology Over the past 20 years there has been an annual increase in adenocarcinoma of the gastro oesophageal junction (GOJ). The peak age group is between 50 and 60 years, with a male to female ratio of 2:1. There have been parallel increases in adenocarcinoma of the gastric cardia, which now accounts for 50% of all gastric cancers. Despite the rise in gastric cardia tumours, the incidence of gastric cancer is declining, with rates 11% lower in 2000 compared with 1990, due mainly to a decrease in distal gastric tumours. 1,2 Of the aetiological factors, chronic gastro oesophageal reflux disease (GORD) is now well established as a cause, mainly due to the increased risk related to Barrett s metaplasia. Obesity predisposes to hiatus hernia and reflux, and hence contributes mechanically to an increased risk. The hypochlorhydria caused by Helicobacter pylori, resulting in ammonia production of urea by the bacteria protects the lower oesophagus by changing the ph content of the refluxing gastric contents. Eradicating H. pylori infection in the treatment of ulcer and non-ulcer dyspepsia may be inadvertently contributing to the increase in GOJ cancers. Tobacco and alcohol are also contributing factors. Original audit The original audit was conducted in 2014. It was a retrospective study and included 48 patients who had oesophagogastrectomy or gastrectomy surgery between January and September 2014 at Broomfield Hospital, Mid Essex Hospital Services NHS Trust (MEHT). The cases diagnosed as gastrointestinal stromal tumours (GIST) were excluded. The original audit concluded and recommended the following: use correct TNM nomenclature i.e. y prefix introduce the use of microscopy proformas for reporting mandard grading (in post neoadjuvant cases). Aims and objectives The re-audit aims to evaluate the implementation of the recommendations from the initial audit. The re-audit is a retrospective analysis of the upper gastrointestinal (GI) resection specimen reports in relation to macroscopic and microscopic dataset items as recommended by the Royal College of Pathologists (RCPath), 3.4 with relation to: analysis of the correct use of TNM classification ( y ) assessing the use of the departmental GI proforma (for microscopic data items) introduced after the initial audit (2014) analysis of the Mandard grading; including the provision by clinicians of correct clinical details with respect to recording the use of neoadjuvent chemotherapy (NACT). Standards The RCPath and the British Society of Gastroenterology (BSG) 5 strongly advocate the standardisation of reporting guidelines for all gastrointestinal malignancies. For pathologists, the RCPath recommends the use of datasets, outlining the core and non-core items that provide both the patient and clinician with prognostic information, information for the most appropriate management and facilitates audit of diagnostic and therapeutic interventions. Dataset for the histopathological reporting of gastric carcinoma 3 Tumour site Histological type www.rcpath.org Number 181 January 2018 51

cont. Tumour size Tumour morphology cont. Histological differentiation Resection margins (distal/proximal/circumferential) Lymph node status (The dataset states that a minimum of 15 lymph nodes should be harvested.) TNM - Extent of tumour through wall Lymphovascular/ perineural invasion Specimen dimensions Effects of neo-adjuvant chemotherapy Glandular atrophy Intestinal metaplasia Dysplasia Presence of H. pylori Dataset for the histopathological reporting of oesophageal carcinoma 4 Maximum tumour diameter Tumour site/location Maximum depth of invasion Morphology Histological type Tumour differentiation Serosal involvement Vascular invasion Lymph node status Resection margins (PRM/DRM/CRM) Overall dimensions of specimen Effects of neoadjuvant therapy Presence of Barrett s metaplasia Molecular data Lymph node status Gastric carcinoma dataset The dataset states: Ideally at least 15 nodes should be recovered from a gastric cancer resection specimen, but the possible yield will depend upon the type of surgical resection performed. Every effort is made to do this and a further harvest is sought if the number falls short during the initial search. Oesophagus carcinoma dataset The dataset does not state the number of lymph nodes that should be harvested from the specimen. As a compromise and taking the gastric dataset into consideration, Broomfield Histopathology Department makes the effort to harvest at least 15 lymph nodes from each specimen. TNM staging Criteria used in the 7th edition of the American Joint Committee on Cancer (AJCC) edition of staging tumours: GOJ tumours a tumour, the epicenter of which is within 5 cm of the GOJ and also extends into the oesophagus, is classified and staged according to the oesophageal scheme A tumour, with an epicenter in the stomach greater than 5 cm from the GOJ or those within 5 cm of the GOJ without extension into the oesophagus, are staged using the gastric scheme. 52 January 2018 Number 181 The Bulletin of The Royal College of Pathologists

The Dataset for the histopathological reporting of gastric carcinoma (2 nd edition) advises: - TNM 7th: pt staging - TNM 5th: pn staging. Furthermore, any tumour nodule >3 mm in the connective tissue of a lymph drainage area, without histologic evidence of a residual lymph node, is classified as node metastasis. Method The cases were identified from a computerised SNOMED search via the Winpath system and anonymised. This retrospective re-audit included 42 patients who had oesophagogastrectomy or gastrectomy surgery between August 2015 and March 2016 at Broomfield Hospital, MEHT. The cases diagnosed as GIST were excluded. Of the 42 cases, 35 were oesophagogastrectomies and 7 were gastrectomies (total, sub-total or distal). All the core data items were extracted from the reports, for both types of specimens. Special note was made about the provision of information regarding neo-adjuvant therapy by the clinicians. Results Total number of cases = 42 Gastrectomy = 7 cases Total gastrectomy = 2 cases Distal/subtotal gastrectomy = 5 cases Oesophagogastrectomy = 35 cases Gastrectomy specimens Number of cases (%) Further information (provided in reports) Specimen dimensions 100% (7/7) Provided in three dimensions Site of tumour 57% (4/7) Distal area/distal margin/lesser curve Tumour dimensions 86% (6/7) Provided in two dimensions Number of cases (%) Further information (provided in reports) Tumour morphology 100% (7/7) Ulcerated/nodular/thickened Distance to nearest margin 86% (6/7) Not provided in 1 case Type of tumour 100% (7/7) Adenocarcinoma Lauren s classification 100% (7/7) Diffuse (4/7), Intestinal (1/7), Mixed (2/7) Lymphovascular invasion 100% (7/7) Present (6/7), Absent (1/7) CRM clearance 100% (7/7) Clear (2/7), Involved (1/7), Not applicable (4/7) Longitudinal margin clearance 100% (7/7) Clear (5/7), PRM involved (1/7), DRM involved (1/7) TNM classification 100% (7/7) Correctly stated in all cases Nodal yield 100% (7/7) Total node range 9 43. Involved node range 2 17 NACT: Recorded by clinicians in 20/35 cases Mandard tumour regression grade given 19/20 cases y prefix provided in 16/20 cases Oesophagogastrectomy specimens Number of cases (%) Further information (provided in reports) Specimen dimensions 100% (35/35) Provided in three dimensions Site of tumour 100% (35/35) GOJ, distal, proximal oesophagus, stomach Tumour dimensions 100% (35/35) Provided in two dimensions Tumour morphology 88% (31/35) Ulcerated/nodular/thickened/polypoidal Tumour to longitudinal margin 88% (31/35) Not stated in 4/35 www.rcpath.org Number 181 January 2018 53

Number of cases (%) Further information (provided in reports) Tumour type 100% (35/35) Adenocarcinoma 32/35, no lesion seen 3/35 Lauren s classification 100% (35/35) Where applicable Tumour differentiation 88% (31/35) 1/35 NACT given but tumour not graded 3/35 tumour not seen microscopically Lymphovascular invasion 91% (32/35) In 3/35 cases tumour not seen, hence not applicable CRM clearance 91% (32/35) In 3/35 cases tumour not seen, hence not applicable Longitudinal margin clearance 100% (35/35) Clear 31/35, DRM involved 1/35, No tumour in 3/35 cases, hence not applicable TNM classification 100% (35/35) Provided in all cases Nodal yield 100% (35/35) Total node range 7 58. Involved node range 1 27 NACT: Recorded by clinicians in 20/35 cases Mandard tumour regression grade given 19/20 cases y prefix provided in 16/20 cases Comparison of audit vs re-audit (gastrectomies) Macroscopy Number of cases 17 7 NACT information not provided 82% (14/17) 72% (5/7) Specimen dimensions 100% (17/17) 100% (7/7) Site of tumour 88% (15/17) 57% (4/7) Tumour dimensions 94% (16/17) 86% (6/7) Distance to nearest margins 88% (15/17) 86% (6/7) Microscopy Type of tumour 100% (17/17) 100% (7/7) Lauren s classification 82% (14/17) 100% (7/7) Tumour differentiation 94% (16/17) 100% (7/7) LVI 94% (16/17) 100% (7/7) CRM clearance 100% (17/17) 100% (7/7) Longitudinal margin clearance 100% (17/17) 100% (7/7) Nodal yield (15 or more nodes) 88% (15/17) Total range 11 40 Involved nodes 1 13 86% (6/7) Total range 9 43 Involved nodes 2 17 TNM 88% (15/17) 100% (7/7) 54 January 2018 Number 181 The Bulletin of The Royal College of Pathologists

Graph 1: comparison of audit vs re-audit (gastrectomies) microscopy Comparison of audit vs re-audit (oesophagogastrectomies) Macroscopy Total number of cases 31 35 NACT information not provided 70% (22/31) 29% (10/35) Specimen dimension 100% (31/31) 100% (35/35) Site of tumour 52% (16/31) 100% (35/35) Tumour dimension 100% (31/31) 86% (6/7) Distance to nearest margin 90% (28/31) 89% (31/35) Microscopy Type of tumour 100% (31/31) 100% (35/35) Tumour differentiation 90% (28/31) 100% (35/35) LVI 90% (28/31) 100% (35/35) CRM clearance 93% (29/31) 100% (35/35) Longitudinal margin clearance 96% (30/31) 100% (35/35) Nodal yield 94% (29/31) Total range 10 46 Involved nodes 1 19 TNM 100% (31/31) (Incorrect TNM in 5/31; 4 cases - pt2a/2b to pt3; 1 cases pn1 to pn2) 86% (30/35) Total range 7 58 Involved nodes 1 27 100% (35/35) Mandard grade y prefix 66% (6 of the 9 cases which had 11% (1 of the 9 cases which had 95% (19 of the 20 cases which had 80% (16 of the 20 cases which had www.rcpath.org Number 181 January 2018 55

Graph 2: comparison of audit vs re-audit (oesophagogastrectomies) microscopy Conclusion Gastrectomy specimens The results show that the microscopic core data item results have improved. However, some of the macroscopic core data item results have not been recorded in some reports. These include: tumour site, dimensions, and distance to nearest margin oesophagogastrectomy specimens again, the microscopic core data items have improved. The only macroscopic core data item not recorded in some reports is the distance to the nearest margin. The lymph node yield is slightly decreased for both types of specimens. Recommendations Remind clinical colleagues to provide NACT information. Continue to use correct TNM classification ( y prefix in appropriate cases). Continue to use Mandard grading (in appropriate cases). Continue to use proformas for microscopy (as recommended in the initial audit of 2014). Consider and discuss the introduction of a template for the macroscopic core data items. Proposed template for macroscopic examination of gastric carcinoma References for this audit are online at www. rcpath.org/jan2018refs Template for Gastric Cancer Examination Name: DOB: Histology Number: Type of specimen: Specimen dimensions: Tumour location/site: Maximum tumour size: Morphology of tumour: Distance of tumour from PRM: Distance of tumour from DRM: Proposed template for macroscopic examination of oesophageal carcinoma Template for Oesophageal Cancer Examination Name: DOB: Histology Number: Type of specimen: Specimen dimensions: Tumour location/site: Maximum tumour size: Morphology of tumour: Maximum anatomical depth of tumour Distance of tumour from CRM: Distance of tumour from PRM: Distance of tumour from DRM: Extended resection (Oesophageal adventitia/crura of diaphragm): YES/NO Dr Manisha Ram Consultant Histopathologist Broomfield Hospital, Chelmsford Dr Moina Kadri Specialty Doctor Histopathology Broomfield Hospital, Chelmsford 56 January 2018 Number 181 The Bulletin of The Royal College of Pathologists